MAUDE Adverse Event Report: DISCUS DENTAL, LLC PHILIPS ZOOM; ZOOM CHAIRSIDE WHITENING KIT

Model Number	881055701540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144); Caustic/Chemical Burns (2549)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(4) 2017 in which dental hygienist reported that after in-office teeth whitening procedure, patient felt nauseous and went to hospital after vomiting blood.The patient also experienced burning on tongue and roof of the mouth.The dental assistant stated that the patient swallowed the gel and had a lot of salivation during the whitening procedure.Investigation: the product was used up during the procedure and not available for return.The retain sample of the zoom whitening gel, sku: (b)(4), lot: 17243014 was tested on 10/17/2017 and results were within specifications.Reviewed device history records of zoom whitening kit, sku: 881055701540, udi: (01)(b)(4), lot: 17243005, and zoom whitening gel, sku: (b)(4), lot: 17243014 and no out of specification or discrepancy was found in the records.Reviewed complaints history, no other similar incidents were reported from the same lots.Based on the investigation results and available information, it can be concluded that there was no failure and malfunction in the device.Heavy salivation and swallowing the gel may have contributed to the event.Based on the investigation results, no product failure and out of specification was found and no corrective action is needed.Dfu is adequate and it describes first aid instructions if gel is swallowed, proper isolation steps, candidate qualification, warnings, ingredients, and other precautions.Product was used up during the procedure.
Event or Problem Description
Discus dental received a complaint on (b)(4) 2017 in which dental hygienist reported that after in-office teeth whitening procedure, patient felt nauseous and went to hospital after vomiting blood.The patient also experienced burning on tongue and roof of the mouth.The dental assistant stated that the patient swallowed the gel and had a lot of salivation during the whitening procedure.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE WHITENING KIT
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700 a south baker ave; ontario CA 91761
• MDR Report Key: 7008133
• Report Number: 1000582314-2017-00009
• Device Sequence Number: 11045523
• Product Code: EEG
• UDI-Device Identifier: 00075020035004
• UDI-Public: (01)00075020035004(10)17243005(17)181202
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dental Assistant
• Device Expiration Date: 12/02/2018
• Device Model Number: 881055701540
• Device Lot Number: 17243005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization